Presentation on theme: "Steven Corns Ajay Thukral Jack Stein"— Presentation transcript:
1Steven Corns Ajay Thukral Jack Stein INCOSE Biomedical-Healthcare Working Group (BHWG) Model-Based Systems Engineering (MBSE) Challenge Team Meeting Monday, January 27, 2014Steven CornsAjay ThukralJack Stein
2Biomedical-Healthcare Model-Based Systems Engineering (MBSE) Challenge Team AgendaIntroductions – (5 min)Modeling Efforts – (10 min)Industry Standards, Compliance, Assurance – (15 min)Integration of Dr. Insup Lee’s work – (15 min)MBSE Position Paper – (15 min)Presentation by Drew Pihera
5Biomedical-Healthcare Engineering and Application Environment Medical DevicesPharmaceuticalsHealthcare Facilities and EquipmentIT Systems / Medical RecordsModels, Analysis, & SimulationsStandards & RegulationsTechnologiesTranslation ofElements ofClinical CareHealthSystems
6Biomedical-Healthcare System Solutions …are we there?Each Biomedical-Healthcare System strives to be a preeminent leader in clinical care, education, research and service. These are measured by objective evidence and established best practices….."Vision that guides Biomedical-Healthcare SystemsTRADITIONAL PRESSURESPROCESS OPTIMIZATION“For full effectiveness, all the work needs to be integrated into a unified program for performance.”Peter Drucker"If it can be measured, it can be managed [and improved]“Jack WelchHEALTHCARE REFORMCMS / PAYERSKPI’s MetricsBalance ScorecardHoshin KanriACCOUNTABLE CARE ORGSLean & Six Sigma6
7Systems Challenges in the Biomedical-Healthcare Sectors Examples .…Healthcare Cost ReductionElectronic Health RecordsMobile Medical Apps - Remote & TelemedicineMedical Device InteroperabilityCounter Bioterrorism CoordinationUniversal Healthcare CoverageYour system challenges ?
8Issues to be Addressed Time to adoption Ensure regulatory, compliance, and risk management requirements are metCost reductionConsistency across device designOthers?
10INCOSE Biomedical-Healthcare Working Group (BHWG) MBSE Challenge Team One of over a dozen INCOSE MBSE Challenge and Activity Teams / Formed in 2011Information is public domain (OMG MBSE Wiki Site)Current Modeling Project:Infusion and Drug Delivery System (IDDS) ModelMeetingsRegular teleconference WebEx meetingsPeriodically face-to-face (Missouri S&T St. Louis Campus, INCOSE Conferences, and International Workshop)
11Challenge Team Mission, Vision, Charter Demonstrate the value and utility of MBSE for biomedical-healthcare related applications and programsProvide INCOSE BHWG members a reference design to adopt for their specific drug, device, and/or biological product development effortsProject Overview:Involve BHWG members in the use of MBSE thus expanding the application beyond defense and aerospace industry related projects.Develop frameworks and templates that can be used to accelerate the development and approval of biomedical devices.Investigate the integration of risk management, safety assurance, and other aspects related to the regulatory environment.Provide a forum for learning how to make the shift from a document-centric to a model-centric systems engineering environment
12Vision – Enabling Excellence in Biomedical-Healthcare System Engineering Generic Models:Infusion PumpICE (ASTM F2671)LIBRARYStandard InterfacesReusable ElementsInfusion and Drug Delivery System (IDDS) ModelOther Development Systems and ToolsRisk Assessment /Safety Assurance Analysis StructuresStandardsRegulationsOther publications
13Project Status / Team Development Recent Activities:MBSE short course for working group and MBSE team membersPreliminary framework createdWiki site updated to share information on progressMet with University of PennsylvaniaChallenge TeamAll members are welcome (General Interest, Modeler, Leadership/Admin Roles)Willingness to meet with bi-weekly to review model / Complete actions itemsContact a MBSE initiative member in the BHWGSteven CornsSandy FriedenthalJack SteinAjay Thukral
20Mbse challenge team Industry standards, compliance and assurance
21Addressing Risk Up Front Risk tolerance typically lower in medical devicesRisk management a key element in device clearance/approval. New Safety Assurance practices and documentation likely (Infusion Pumps).Device clearance/approval is tightly linked to compliance with standards and regulationsISO (Risk Management)IEC (Usability Engineering)ISO (Software Life Cycle)IEC (Electrical Safety)FDA Design Controls (Needs, Requirements, V&V, etc.)
22Vision – Enabling Excellence in Biomedical-Healthcare System Engineering Generic Models:Infusion PumpICE (ASTM F2671)LIBRARYStandard InterfacesReusable ElementsInfusion and Drug Delivery System (IDDS) ModelOther Development Systems and ToolsRisk Assessment /Safety Assurance Analysis StructuresStandardsRegulationsOther publications
23Integrated Clinical Environment (ICE) Medical Device Plug-and-Play Interoperability “Getting Connected for Safety”
24ASTM F2671 Integrated Clinical Environment (ICE) Figure 1 from ASTM F2671 – Conceptual functional model showing the elements of ICE
25Bring Standards Directly Into the Design/Development Environment: Example – ASTM F2671 ICE (Interoperability)Transform information in standards into integrated model elements, configurations, and views which are directly traceable to use scenarios, requirements, architecture, verification, validation, risk management, safety assurance, and other information.
26SysML Representation of the ASTM F2671 Integrated Clinical Environment (ICE) Model
27Model-Driven Safety Analysis of Closed-Loop Medical Systems – Dr Model-Driven Safety Analysis of Closed-Loop Medical Systems – Dr. Insup Lee
28Overview Model of a patient controlled analgesia (PCA) pump Allows for model with a patient in the loopCreate a model that incorporates this devices with higher level system
35Vision – Enabling Excellence in Biomedical-Healthcare System Engineering Generic Models:Infusion PumpICE (ASTM F2671)LIBRARYStandard InterfacesReusable ElementsInfusion and Drug Delivery System (IDDS) ModelOther Development Systems and ToolsRisk Assessment /Safety Assurance Analysis StructuresStandardsRegulationsOther publications
36Goals Guidelines for using the framework developed Expansion of library of components and methodsContinue integration of ISO/IEC standards and complianceOthers?